MAUDE Adverse Event Report: FH INDUSTRIE CALCANAIL; CALCANAIL NAIL Ø12 LG65MM + CAP_ARTHODESIS

Catalog Number 265549 (US 268314)

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/20/2017

Event Type  Injury  

Event Description

Incident report on (b)(6) 2017: "damage (cracked) nail, no broken, only damaged.Necessary to remove a screw of the implant and put some growth factor".E-mail on december 1st 2017: "differently from the beginning the items was remove".

• Brand Name: CALCANAIL
• Type of Device: CALCANAIL NAIL Ø12 LG65MM + CAP_ARTHODESIS
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: renaud ruillier ; 3 rue de la for[?]t; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 7234297
• MDR Text Key: 98787803
• Report Number: 3003898228-2017-00014
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03661489655494
• UDI-Public: 3661489655494
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K150471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2021
• Device Catalogue Number: 265549 (US 268314)
• Device Lot Number: G02533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR